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NCT Number: NCT06268444

Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants

During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child's diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed.

In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant's milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation.

Recruiting

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Key information

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Amiens

Amiens, 80054, France

Location status: Recruiting

Location contact

Elodie HARAUX, HARAUX

PRINCIPAL_INVESTIGATOR

Karen CHARDON, Pr

CONTACT

[email protected]

03.22.82.78. 65

Pierre TOURNEUX, Pr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infant less than 6 months of age still on milk diet (total)

Exclusion criteria

  • Infants with neurological or neurobehavioral disorders
  • Families who wish to relocate within 7 days of inclusion
  • Minor parents deprived of their parental rights, not understanding French, in a state of stress, overwhelmed or vulnerable.
  • Non-affiliation to a social security system

Treatment and study plan

7-day actimetry sleep recording

Device

7-day actimetry sleep recording

Determination of environmental pollutants in breast milk

Other

Determination of environmental pollutants in breast milk

Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child

Other

Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child

Continuous recording of the child's temperature for 7 days

Other

Continuous recording of the child's temperature for 7 days

Use of a sleep diary for 7 days

Other

Use of a sleep diary for 7 days

Parental questionnaire of environmental exposure

Other

Parental questionnaire of environmental exposure

Primary outcomes

  1. total sleep time per day in infants using actimetry

    Time frame: 7 days

    total sleep time per day (min)) in infants using actimetry

Secondary outcomes

  1. Concentration of various substances in breast milk

    Time frame: 1 day

  2. concentration of chemical polluants on newborn bracelets

    Time frame: 1 day

  3. Child Temperature level (°C)

    Time frame: 7 days

Study contacts

Contact information is provided by the study sponsor or research team.

Elodie HARAUX, Pr

CONTACT

[email protected]

(33) 03.22.08.75.60

Karen CHARDON, Pr

CONTACT

[email protected]

(33) 03.22.82.78. 65

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Infant Sleep and Exposure to Mixture of Environmental Pollutants

Acronym: SOLANGE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2024
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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